Complaint says similarities between Gilead's Biktarvy and ViiV's dolutegravir suggest Gilead copied ViiV's drug.
Gilead Sciences Inc. is once again in the middle of a high stakes patent brawl as ViiV Healthcare claims Gilead's new HIV combination therapy Biktarvy (BIC/TAF) is insubstantially different from ViiV's dolutegravir.
ViiV filed a patent infringement suit against Gilead in the US District Court for the District of Delaware on...
The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
An effort to change the US Food and Drug Administration’s conclusion that its obesity treatment candidate retatrutide is a drug and not a biologic could give the product more time with unrestricted pricing in Medicare, among other benefits.
Glenmark Pharmaceuticals agreed to pay $25m in the US to resolve its alleged liability under the False Claims Act linked to price-fixing allegations.
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
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